pdufa.bio
HomeFDA Decisions › MIST 2025-12-15

MIST FDA Decision Approved · 2025-12-15

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 12/15/25$2.95$1.386/30/25
Daily close, T-120 (6/30/25) through T+5. Run-up high $2.95 on 12/11/25, low $1.38 on 7/16/25 (T-120 to T-1). FDA decision 12/15/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 1, 2025, 14 days before the decision date, at-the-money options priced a move of ±46.3% through Dec 19, 2025 (the first listed expiry after the decision; ATM implied volatility 274%). The stock closed -2.7% at the first close across the decision and -10.8% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-12-15
DrugCARDAMYST (etripamil)
IndicationParoxysmal supraventricular tachycardia (PSVT)
Outcome✓ Approvedprimary-sourced
Decision-day move-2.5%
T-120 run-up (low→high)+70.0% ($1.64→$2.95)
Market-cap tierNano
Cohort decision-day move (history)8.0% median (n=117)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Questions

Was CARDAMYST (etripamil) approved by the FDA?

Yes. The FDA approved the application for CARDAMYST (etripamil) on December 15, 2025. The primary source is linked on this page.

What was CARDAMYST (etripamil) under FDA review for?

The application covered Paroxysmal supraventricular tachycardia (PSVT). The FDA approved the application on December 15, 2025.

How did MIST stock react to the FDA decision?

On the decision day MIST moved -2.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.